Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06534190

CD8 PET Imaging in Metastatic Solid Tumours

Led by University Medical Center Groningen · Updated on 2026-02-09

30

Participants Needed

4

Research Sites

190 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a multi-center, single-arm trial designed to evaluate the safety and imaging characteristics of 89Zr-Df-crefmirlimab in patients with locally advanced or metastatic solid tumours prior to and during PD-1 antibody therapy.

CONDITIONS

Official Title

CD8 PET Imaging in Metastatic Solid Tumours

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older at time of consent
  • Histologically confirmed locally advanced or metastatic solid cancer suitable for anti-PD1 therapy
  • Disease progression after first-line therapy or no better standard treatment available
  • At least one lesion accessible and eligible for biopsy
  • Measurable disease by RECIST v1.1 criteria
  • ECOG performance status 0 or 1
  • Life expectancy of at least 12 weeks
  • Adequate organ and bone marrow function as defined by specific blood counts and liver/kidney function
  • Signed informed consent
  • Willingness and ability to comply with study procedures
  • Agreement to use highly effective contraception for patients of childbearing potential
Not Eligible

You will not qualify if you...

  • Treatment with anti-cancer therapy or investigational agents within 28 days before study drug
  • Untreated symptomatic brain metastases, leptomeningeal disease, or spinal cord compression
  • Prior immune checkpoint inhibitor treatment
  • Major surgery within 28 days before study drug or planned during study
  • History of autoimmune diseases except controlled hypothyroidism or type I diabetes
  • Systemic immunosuppressive medication within 4 weeks before study drug
  • Prior allogeneic bone marrow or solid organ transplant
  • Active infections like HIV, hepatitis B or C, tuberculosis, or immunodeficiency
  • Receipt of live vaccine within 30 days before study drug
  • Active infection requiring systemic antibiotics within 2 weeks before study drug
  • Less than 2 weeks from recovery of documented COVID-19 infection
  • Medical or psychiatric conditions impairing informed consent or study participation
  • Sponsor employees or immediate family
  • Positive pregnancy test or breastfeeding
  • Unwillingness to use effective contraception
  • Contraindications for MRI scan
  • Splenic disorders or splenectomy affecting study objectives

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

VUMC

Amsterdam, Netherlands, 1081 HV

Actively Recruiting

2

University Medical Center Groningen

Groningen, Netherlands, 9713 GZ

Actively Recruiting

3

Vall d'Hebron Institute of Oncology (VHIO) / Vall d'Hebron Institute Research (VHIR)

Barcelona, Spain, 08035

Not Yet Recruiting

4

University of Cambridge

Cambridge, United Kingdom, CB2 1TN

Not Yet Recruiting

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Research Team

E

Elisabeth GE de Vries, MD, PhD

CONTACT

D

Daan G. Knapen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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